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Glasgow, SCOTLAND. Sistemic Ltd. is excited to announce significant progress with the development of a miRNA-based assay for assessment of pluripotent stem cell (PSC) contamination in derived cell therapy products. The development is being undertaken in conjunction with LGC, the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement.

The work at Sistemic is being supported by the UK’s innovation agency, Innovate UK, under the “Analysis for Innovators” grant. Significant progress has already been made in optimising the assay to improve sensitivity and performance. Based on this progress, testing of assay with clinical products is planned in Q4 2017, with the assay being on course for early release at the beginning of 2018.

Jim Reid, CEO stated "this is a major step forward in the assessment of cellular contamination and will be a great help to companies developing iPSC-derived products. It is also the second product in our SistemCheck™ range and continues our development of novel products and other analytical technologies targeted at the Cell and Gene Therapy sector. This sector will make a significant contribution to the treatment of many diseases in the future but the industry also needs to have robust analytical products and this is what SistemCheck™ can bring”

David Mallinson, VP of Scientific Operations added "We are delighted with the significant progress that has been made so far in further optimising the assay. The assay shows great promise and has the potential to facilitate the clinical progress of pluripotent stem cell-derived cell therapy products, allowing them to be developed to safer clinical products more quickly"
Potential partners interested in receiving further information on the availability of the test or to be part of an Early Access Programme should contact press@sistemic.co.uk

About Sistemic
Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell and Gene Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. Furthermore, cell products in the later stages of clinical development benefit from SistemQC™ miRNA-based profiling approach in facilitating patient stratification and monitoring the response to the treatment. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™. Sistemic has a worldwide customer base and a strong intellectual property portfolio.

About LGC
LGC is an international life sciences measurement and testing company with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, genomics reagents and instrumentation, and expert sample analysis and interpretation. LGC serves customers across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Diagnostics, Food, Environment, Government and Academia.
LGC’s headquarters are in London and the company employs over 2,600 people, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025, ISO 13485, ISO 9001, GMP, GLP and ISO Guide 34.
With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC was privatised in 1996 and is now owned by funds affiliated with KKR.

Recent News

Glasgow, SCOTLAND. Sistemic Ltd. is excited to announce significant progress with the development of a miRNA-based assay for assessment of pluripotent stem cell (PSC) contamination in derived cell therapy products. The development is being undertaken in conjunction with LGC, the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement.

Sistemic Ltd. announced today the publication of its ground-breaking research, undertaken together with TiGenix, identifying a set of circulating miRNA biomarkers which could potentially be used, if further clinically validated, to stratify refractory rheumatoid arthritis patients, prior to treatment, into responders and non-responders to an allogenic cell-based therapy:

Our Products

Sistemic’s platform technology pioneering the approach and development of miRNA-based profiling tools to guide and support Cell Therapy (CT) product development and drug discovery and repositioning

Allows for robust miRNA profiling, customised multi-layered statistical analysis, and biological interpretation and identification of the key markers (KmiR’s™) of cell phenotype. Whilst also seeking to maximise the utility and value of the KmiR’s™ identified

Sistemic's methodologies can also be applied to define, qualify and validating miRNA biomarkers from biofluids and surgical samples for prediction, diagnostic, prognostic, monitoring, toxicity and end-point.

Sistemic’s highly curated knowledge from internal and external projects covering miRNA and cell therapy-based knowledge. The database includes kmiR™ lists from all analyses and high impact meta-data. The knowledgebase is fully integrated with SistemSeek™ literature database